REVITAN RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-08 for REVITAN RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501 manufactured by Zimmer Gmbh.

MAUDE Entry Details

Report Number0009613350-2019-00429
MDR Report Key8766528
Date Received2019-07-08
Date of Report2019-07-11
Date Mfgr Received2019-07-10
Device Manufacturer Date2012-09-17
Date Added to Maude2019-07-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameREVITAN RASP ADAPTER WITH LENGTH MARKINGS
Generic NameREVITAN RASP ADAPTER
Product CodeHTR
Date Received2019-07-08
Model NumberN/A
Catalog Number01.00409.501
Lot Number12783902
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.